Cleared Traditional

K011036 - RD-3008

K011036 is an FDA 510(k) clearance for RD-3008, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K011036 · Heraeus Kulzer, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
35d
Days
Class 2
Risk

K011036 is an FDA 510(k) clearance for the RD-3008. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Armonk, US). The FDA issued a Cleared decision on May 10, 2001 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K011036

510(k) Number K011036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2001
Decision Date May 10, 2001
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 127d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EJT Alloy, Gold-based Noble Metal

All 489
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K011036.
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COSMIC
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